Ultrasound diagnostic apparatus and control method of ultrasound diagnostic apparatus

The present application claims priority under 35 U.S.C. § 119 to Japanese Patent Application No. 2022-096332, filed on Jun. 15, 2022. The above application is hereby expressly incorporated by reference, in its entirety, into the present application.

The present invention relates to an ultrasound diagnostic apparatus and a control method of the ultrasound diagnostic apparatus, and particularly to an ultrasound diagnostic apparatus which determines a medical examination category or a diagnosis category of a lesion part according to a predetermined determination procedure with a plurality of branches.

In the related art, in the medical field, an ultrasound diagnostic apparatus using an ultrasound image has been put to practical use. In general, an ultrasound diagnostic apparatus includes an ultrasound probe with a built-in transducer array, and an apparatus main body connected to the ultrasound probe, and the ultrasound diagnostic apparatus causes the ultrasound probe to transmit an ultrasound beam toward a subject, receives an ultrasound echo from the subject by the ultrasound probe, and electrically processes a reception signal thereof to generate an ultrasound image.

JP2005-342028A discloses a device that assists an examination for a subject by determining benignancy or malignancy of a lesion part on the basis of an image such as an ultrasound image in which the lesion part of the subject is imaged.

Sequential determination options are presented according to the predetermined examination procedure, the determination is executed by referring to the information on the lesion part acquired by various tools such as a measurement tool, and the history of each determination is displayed with a thick line on the diagram in which the entire examination procedure is illustrated in a tree form. Furthermore, the information on the measurement value or the like of the lesion part which is acquired by the tool and serves as the basis of the determination is displayed corresponding to each determination.

However, in order to determine the benignancy or malignancy of the lesion part, a plurality of ultrasound images represented as a video are referred to in many cases, and in this case, there is a possibility that the basis of the determination cannot be accurately understood even in a case where the information on the measurement value or the like of the lesion part is displayed together with the history of the determination.

The present invention has been made in order to solve the problems in the related art, and an object thereof is to provide an ultrasound diagnostic apparatus and a control method of the ultrasound diagnostic apparatus which can determine a medical examination category or a diagnosis category of a lesion part and accurately understand the basis of the determination by referring to a plurality of ultrasound images.

According to the following configuration, the above object can be achieved.

a determination procedure memory that stores the determination procedure; an identification unit that identifies characteristics of the lesion part for a determination item for route selection in the plurality of branches of the determination procedure stored in the determination procedure memory on the basis of a plurality of ultrasound images in which the same lesion part is imaged; an extraction unit that extracts at least one ultrasound image contributing to identification of the characteristics in the plurality of branches of the determination procedure by the identification unit, from the plurality of ultrasound images as a basis image; a determination unit that performs the route selection in the plurality of branches of the determination procedure by applying the characteristics identified by the identification unit to the determination item to determine the medical examination category or the diagnosis category of the lesion part; a monitor; and a display controller that displays a route in the determination procedure in a case where the medical examination category or the diagnosis category is determined by the determination unit and the basis image extracted by the extraction unit on the monitor. [1] An ultrasound diagnostic apparatus that determines a medical examination category or a diagnosis category of a lesion part according to a predetermined determination procedure having a plurality of branches, the ultrasound diagnostic apparatus comprising:

[2] The ultrasound diagnostic apparatus described in [1], in which the plurality of ultrasound images are images forming a video in which the lesion part is imaged.

[3] The ultrasound diagnostic apparatus described in [1] or [2], in which each of the plurality of ultrasound images is an image in which an entire or a part of the lesion part is imaged.

[4] The ultrasound diagnostic apparatus described in [2] or [3], in which the plurality of ultrasound images are a thinned-out image, an interpolated image, or a synthesized image from the images forming the video in which the lesion part is imaged.

[5] The ultrasound diagnostic apparatus described in any one of [1] to [4], in which the extraction unit forms an enclosing line surrounding a portion contributing to the identification of the characteristics by the identification unit, in the basis image, and the display controller superimposes and displays the enclosing line on the basis image.

[6] The ultrasound diagnostic apparatus described in any one of [1] to [5], in which the extraction unit forms a heat map in which a contribution rate of a portion contributing to the identification of the characteristics by the identification unit is represented by color shading or color difference, on the basis of the basis image, and the display controller displays the heat map on the monitor.

[7] The ultrasound diagnostic apparatus described in any one of [1] to [6], in which in a case where a plurality of the basis images are extracted for one of the branches by the extraction unit, the display controller displays the plurality of basis images side by side on the monitor.

[8] The ultrasound diagnostic apparatus described in any one of [1] to [7] further comprising an input device for a user to perform an input operation, in which in a case where a plurality of the basis images are extracted for one of the branches by the extraction unit, the display controller sequentially displays the plurality of basis images on the monitor on the basis of the input operation of the user via the input device.

[9] The ultrasound diagnostic apparatus described in [8], in which the display controller displays a page number indicating which of the plurality of basis images is the basis image being displayed on the monitor in an overlaid manner on the basis image.

[10] The ultrasound diagnostic apparatus described in any one of [1] to [9], in which the identification unit measures a size of the lesion part, and the display controller displays the size measured by the identification unit on the monitor.

[11] The ultrasound diagnostic apparatus described in any one of [1] to [10], in which the identification unit calculates a ratio of a region where the identified characteristics appear to an entire region of the lesion part for each determination item, and the display controller displays the ratio calculated by the identification unit on the monitor.

[12] The ultrasound diagnostic apparatus described in any one of [1] to [11], in which the determination unit includes a probability calculation unit that calculates a probability of the route selection in the plurality of branches of the determination procedure on the basis of the characteristics of the lesion part, and the display controller displays the probability calculated by the probability calculation unit on the monitor.

[13] The ultrasound diagnostic apparatus described in [12], in which in a case where a plurality of the medical examination categories or the diagnosis categories correspond to any one of the plurality of branches of the determination procedure, the determination unit compares the probability calculated by the probability calculation unit with a predetermined threshold value to determine the medical examination category or the diagnosis category of the lesion part.

[14] The ultrasound diagnostic apparatus described in any one of [1] to [13], further comprising: an ultrasound probe; and an image generation unit that generates the plurality of ultrasound images in which the same lesion part is imaged, by performing transmission and reception of ultrasound beams with respect to a subject using the ultrasound probe.

a step of identifying characteristics of the lesion part for a determination item for route selection in the plurality of branches of the determination procedure on the basis of a plurality of ultrasound images in which the same lesion part is imaged; a step of extracting at least one ultrasound image contributing to identification of the characteristics from the plurality of ultrasound images as a basis image; a step of performing the route selection in the plurality of branches by applying the identified characteristics to the determination item to determine the medical examination category or the diagnosis category of the lesion part; and a step of displaying a route in the determination procedure in a case where the medical examination category or the diagnosis category is determined and the extracted basis image on the monitor. [15] A control method of an ultrasound diagnostic apparatus that determines a medical examination category or a diagnosis category of a lesion part according to a predetermined determination procedure having a plurality of branches, the control method comprising:

According to the present invention, characteristics of the lesion part for a determination item for route selection in the plurality of branches of the determination procedure stored in the determination procedure memory are identified by the identification unit on the basis of a plurality of ultrasound images in which the same lesion part is imaged, at least one ultrasound image contributing to identification of the characteristics in the plurality of branches of the determination procedure by the identification unit is extracted by the extraction unit from the plurality of ultrasound images as a basis image, a route in the determination procedure in a case where the medical examination category or the diagnosis category is determined and the basis image extracted by the extraction unit are displayed on the monitor. Therefore, it is possible to determine the medical examination category or the diagnosis category of the lesion part and accurately understand the basis for the determination by referring to the plurality of ultrasound images.

Hereinafter, embodiments of the invention will be described with reference to the accompanying drawings.

The description of configuration requirements described below is given on the basis of the representative embodiment of the present invention, but the present invention is not limited to such an embodiment.

In the present specification, a numerical range represented using “to” means a range including the numerical values before and after “to” as a lower limit value and an upper limit value.

In the present specification, the terms “same” and “identical” include an error range generally allowed in the technical field.

1 FIG. 10 20 10 20 illustrates a configuration of an ultrasound diagnostic apparatus according to a first embodiment of the present invention. The ultrasound diagnostic apparatus includes an ultrasound probeand an apparatus main body. The ultrasound probeand the apparatus main bodyare connected to each other in a wired manner via a cable (not illustrated).

10 11 12 11 The ultrasound probeincludes a transducer array, and a transmission and reception circuitis connected to the transducer array.

20 21 12 10 22 23 21 24 21 The apparatus main bodyhas an image generation unitconnected to the transmission and reception circuitof the ultrasound probe, a display controllerand a monitorare sequentially connected to the image generation unit, and an image memoryis connected to the image generation unit.

25 26 24 26 25 27 25 25 26 27 22 32 25 26 27 Each of an identification unitand an extraction unitis connected to the image memory, and the extraction unitis connected to the identification unit. Further, a determination unitis connected to the identification unit, and each of the identification unit, the extraction unit, and the determination unitis connected to the display controller. A determination procedure memoryis connected to the identification unit, the extraction unit, and the determination unit.

28 21 22 24 25 26 27 32 29 28 12 10 28 A main body controlleris connected to the image generation unit, the display controller, the image memory, the identification unit, the extraction unit, the determination unit, and the determination procedure memory, and an input deviceis connected to the main body controller. The transmission and reception circuitof the ultrasound probeis connected to the main body controller.

21 22 25 26 27 28 30 The image generation unit, the display controller, the identification unit, the extraction unit, the determination unit, and the main body controllerconstitute a processor.

11 10 12 The transducer arrayof the ultrasound probehas a plurality of ultrasonic transducers arranged in a one-dimensional or two-dimensional manner. According to a drive signal supplied from the transmission and reception circuit, each of the transducers transmits an ultrasonic wave and receives a reflected wave from the subject to output an analog reception signal. For example, each transducer is configured by forming electrodes at both ends of a piezoelectric body consisting of piezoelectric ceramic represented by lead zirconate titanate (PZT), a polymer piezoelectric element represented by poly vinylidene di fluoride (PVDF), piezoelectric single crystal represented by lead magnesium niobate-lead titanate (PMN-PT), or the like.

12 11 11 28 12 13 11 14 15 16 11 2 FIG. The transmission and reception circuitcauses the transducer arrayto transmit the ultrasonic wave and generates a sound ray signal on the basis of a reception signal acquired by the transducer array, under the control of the main body controller. As illustrated in, the transmission and reception circuithas a pulserconnected to the transducer array, and an amplification unit, an analog digital (AD) conversion unit, and a beam formerthat are sequentially connected in series to the transducer array.

13 13 11 28 11 The pulserincludes, for example, a plurality of pulse generators, and the pulseradjusts the amount of delay of each drive signal so that ultrasonic waves transmitted from the plurality of transducers of the transducer arrayform an ultrasound beam on the basis of a transmission delay pattern selected according to the control signal from the main body controller, and supplies the obtained signals to the plurality of transducers. Thus, in a case where a pulsed or continuous-wave voltage is applied to the electrodes of the transducers of the transducer array, the piezoelectric body expands and contracts to generate pulsed or continuous-wave ultrasonic waves from each transducer. From the combined wave of these ultrasonic waves, an ultrasound beam is formed.

11 10 11 11 11 14 The transmitted ultrasound beam is reflected by a target, for example, a site of the subject, and the ultrasound echo propagates toward the transducer arrayof the ultrasound probe. The ultrasound echo propagating toward the transducer arrayin this manner is received by each transducer constituting the transducer array. In this case, each transducer constituting the transducer arrayexpands and contracts by receiving the propagating ultrasound echo to generate a reception signal that is an electric signal, and outputs the reception signal to the amplification unit.

14 11 15 15 14 16 16 15 28 15 The amplification unitamplifies the signals input from each transducer constituting the transducer array, and transmits the amplified signals to the AD conversion unit. The AD conversion unitconverts the signal transmitted from the amplification unitinto digital reception data, and transmits the reception data to the beam former. The beam formerperforms so-called reception focusing processing in which addition is performed by giving delays to respective pieces of the reception data converted by the AD conversion unitaccording to a sound speed distribution or a sound speed set on the basis of a reception delay pattern selected according to the control signal from the main body controller. Through the reception focusing processing, a sound ray signal in which each piece of the reception data converted by the AD conversion unitis phased and added and the focus of the ultrasound echo is narrowed is acquired.

3 FIG. 21 20 41 42 43 As illustrated in, the image generation unitof the apparatus main bodyhas a configuration in which a signal processing unit, a digital scan converter (DSC), and an image processing unitare sequentially connected in series.

41 12 10 The signal processing unitgenerates an ultrasound image signal (B-mode image signal), which is tomographic image information regarding tissues inside the subject, by performing, on the sound ray signal sent from the transmission and reception circuitof the ultrasound probe, correction of the attenuation due to the distance according to the depth of the reflection position of the ultrasonic wave and then performing envelope detection processing.

42 41 The DSCconverts (raster conversion) the ultrasound image signal generated by the signal processing unitinto an image signal according to a normal television signal scanning method.

43 42 22 24 21 The image processing unitperforms various kinds of necessary image processing such as gradation processing on the ultrasound image signal input from the DSC, and then outputs the signal representing the ultrasound image to the display controllerand the image memory. The signal representing the ultrasound image generated by the image generation unitin this manner is simply referred to as an ultrasound image.

24 21 28 24 21 The image memoryis a memory that stores the ultrasound image generated by the image generation unitunder the control of the main body controller. For example, the image memorycan hold the ultrasound images of a plurality of frames, which are generated by the image generation unit, corresponding to the diagnosis for the breast of the subject.

24 Here, as the image memory, recording media such as a flash memory, a hard disc drive (HDD), a solid state drive (SSD), a flexible disc (FD), a magneto-optical disc (MO disc), a magnetic tape (MT), a random access memory (RAM), a compact disc (CD), a digital versatile disc (DVD), a secure digital card (SD card), and a universal serial bus memory (USB memory), or the like can be used.

32 32 4 FIG. The determination procedure memoryis a memory that stores a predetermined determination procedure for determining which one of a plurality of standardized medical examination categories does the patient fall into on the basis of the benignancy or malignancy of the lesion part. For example, as illustrated in, the determination procedure for determining the medical examination category of a mass formed in the mammary glands is stored in the determination procedure memory. The determination procedure is shown in the guideline created by the Japanese Association of Breast and Thyroid Sonology (JABTS), and has a plurality of branches in which the route is divided according to each determination item.

32 As the determination procedure memory, for example, a flash memory, an HDD, an SSD, an FD, an MO disc, an MT, a RAM, a CD, a DVD, an SD card, and a USB memory can be used.

Medical examination category 1: no abnormal findings Medical examination category 2: there are findings but detailed examination is not required Medical examination category 3: benign but malignancy cannot be ruled out Medical examination category 4: suspicious of malignancy Medical examination category 5: malignant JABTS defines medical examination categories 1 to 5 as follows.

1 For example, in a first branch B, three determination items of a cystic pattern (non-echo), a mixed pattern (having a solid part and a liquid part), and a solid pattern are set regarding ultrasound echoes from the mass inside in the ultrasound image.

Then, in a case where the cystic pattern is selected on the basis of the characteristics of the ultrasound echoes, it is determined that the mass belongs to the medical examination category 2, and in a case where the mixed pattern is selected, it is determined that the mass belongs to the medical examination categories 3 and 4, but it is determined that the tumor belongs to the medical examination category 2 in a case where the maximum diameter of the tumor is 5 mm or less.

1 2 In the branch B, in a case where the solid pattern is selected, in a case of corresponding to “the maximum diameter is 2 cm or less, the aspect ratio is sufficiently small, and the circumference is clear and smooth” or the like according to the characteristics of the ultrasound echo, it is determined that the tumor belongs to the medical examination category 2, and in a case of not corresponding thereto, the determination proceeds to a next branch B.

2 In the branch B, a border portion hyperechoic image and the rupture of the mammary gland border line are set as the determination items, in a case of corresponding to at least one of the border portion hyperechoic image or the rupture of the mammary gland border line, it is determined that the mass belongs to medical examination categories 4 and 5. In a case of corresponding to neither the border portion hyperechoic image nor the rupture of the mammary gland border line, the medical examination category is determined according to whether or not there are a plurality of fine and punctate hyperechoic portions, and according to the maximum diameter of the tumor and the aspect ratio of the mass. Furthermore, the medical examination categories may be adjusted depending on the shape of the mass.

1 2 3 1 3 1 2 1 2 3 5 FIG. 6 FIG. Here, for example, the diameter of the tumor is expressed as L×L×L[mm] by measuring a maximum length Lof a tumor N and a maximum width Lon a line orthogonal to the maximum length Lin a cross section including the maximum dimension of the tumor N as illustrated in, and further measuring a maximum diameter Lin a cross section orthogonal to the cross section including the maximum dimension of the tumor N as illustrated in. These maximum length L, maximum diameter L, and maximum width Lare measured including a border hyperechoic portion H.

7 FIG. The aspect ratio of the mass can be expressed as a value obtained by measuring a horizontal diameter W of a mass M in a direction parallel to the body surface (skin) of the subject and a vertical diameter D in a direction orthogonal to the horizontal diameter W without including the border hyperechoic portion, for example, as illustrated in, and dividing the vertical diameter D by the horizontal diameter W.

8 FIG. 9 FIG. 10 FIG. 11 FIG. Further, for example, the shape of the mass is classified into a circular shape or oval shape (without narrow part, without angulated part) as illustrated in, a polygonal shape (without narrow part, with angulated part) as illustrated in, a lobulated shape (with narrow part, without angulated part) as illustrated in, and an irregular shape (with narrow part, with angulated part) as illustrated in, according to whether or not the shape including the border hyperechoic portion has a “narrow part” and an “angulated part”.

25 32 21 24 25 4 FIG. The identification unitidentifies the characteristics of the lesion part for the determination items for the route selection in the plurality of branches of the determination procedure as illustrated inby reading out the determination procedure from the determination procedure memoryand analyzing the plurality of ultrasound images that are generated by the image generation unitand are stored in the image memory. The “cystic pattern”, the “mixed pattern”, the “solid pattern”, the “border portion hyperechoic image”, the “rupture of the mammary gland border line”, the “fine and punctate hyperechoic portions”, the “maximum diameter of the tumor”, the “aspect ratio of the mass”, the “shape of the mass”, the “narrow part”, the “angulated part”, and the like which are exemplified in the determination procedure described above correspond to the characteristics of the lesion part to be identified by the identification unit.

25 The identification of the characteristics of the lesion part in the identification unitcan be executed by using at least one of template matching, an image analysis technique using feature amounts such as Adaptive Boosting (Adaboost), support vector machines (SVM), or scale-invariant feature transform (SIFT), or a determination model trained using a machine learning technique such as deep learning. The determination model is a trained model that is trained using learning ultrasound images of the breast including a lesion region, for example.

25 By the identification unit, the border of the lesion part is determined, and the size such as the maximum diameter and the aspect ratio of the lesion part is measured on the basis of the border.

25 The plurality of ultrasound images to be analyzed by the identification unitmay form a video in which the same lesion part of the subject is imaged, and each of the plurality of ultrasound images is an image in which the entire or a part of the lesion part is imaged.

25 The identification unitmay analyze the plurality of ultrasound images forming the video in which the lesion part is imaged as it is, or can analyze an image thinned out of the plurality of ultrasound images forming the video, an image interpolated with respect to the plurality of ultrasound images forming the video, or an image synthesized from the plurality of ultrasound images forming the video.

25 25 26 27 The identification result of the characteristics of the lesion part by the identification unitis sent from the identification unitto the extraction unitand the determination unit.

26 25 25 21 24 4 FIG. The extraction unitreceives the identification result of the characteristics of the lesion part from the identification unit, and extracts, as the basis image, at least one ultrasound image contributing to the identification of the characteristics in the plurality of branches of the determination procedure by the identification unit, from the plurality of ultrasound images that are generated by the image generation unitand stored in the image memory. That is, in the plurality of branches of the determination procedure illustrated in, in a case of determining whether or not the characteristics of the lesion part correspond to the determination item, the ultrasound image that best represents the determination, that is, the ultrasound image that is a decisive factor for the determination is extracted.

In this case, for example, the likelihood of determining each characteristic corresponding to the branch of the determination procedure is scored and recorded for the plurality of ultrasound images, the characteristic with the highest score or the characteristic with the highest mean, median, or mode of the scores of the plurality of ultrasound images is selected as a branch route, and the ultrasound image with the highest score of the characteristic corresponding to the selected route is extracted as the basis image.

26 The number of extracted ultrasound images is not limited to one, and the extraction unitcan extract a plurality of ultrasound images as the basis image.

27 25 25 32 The determination unitreceives the identification result of the characteristics of the lesion part from the identification unit, performs the route selection of the determination procedure by applying the characteristics of the lesion part identified by the identification unitto the determination item corresponding to each branch in the plurality of branches of the determination procedure stored in the determination procedure memory, and thereby determines the medical examination category of the lesion part.

22 21 23 28 The display controllerperforms predetermined processing on the ultrasound image sent from the image generation unit, and displays the ultrasound image on the monitor, under the control of the main body controller.

22 32 23 27 26 23 Further, the display controllerdisplays the determination procedure stored in the determination procedure memoryon the monitor, and displays the route in the determination procedure in a case of determining the medical examination category by the determination unitand the basis image extracted by the extraction uniton the monitorby superimposing the route and the basis image on the determination procedure.

23 22 The monitoris for displaying the ultrasound image, the determination procedure, and the like under the control of the display controller, and includes a display device such as a liquid crystal display (LCD), or an organic electroluminescence (EL) display.

28 20 12 10 The main body controllercontrols each unit of the apparatus main bodyand the transmission and reception circuitof the ultrasound probeon the basis of a control program and the like stored in advance.

28 Although not illustrated, a main body-side storage unit is connected to the main body controller. The main body-side storage unit stores a control program and the. As the main body-side storage unit, for example, a flash memory, a RAM, an SD card, an SSD, and the like can be used.

29 23 The input deviceis for a user to perform an input operation, and is configured by, for example, a device such as a keyboard, a mouse, a trackball, a touchpad, and a touch sensor superimposed on the monitor.

30 21 22 25 26 27 28 30 The processorhaving the image generation unit, the display controller, the identification unit, the extraction unit, the determination unit, and the main body controlleris configured by a central processing unit (CPU) and a control program for causing the CPU to execute various kinds of processing, but the processormay be configured by using a field programmable gate array (FPGA), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a graphics processing unit (GPU), or other integrated circuits (IC) or may be configured by a combination thereof.

21 22 25 26 27 28 30 Further, the image generation unit, the display controller, the identification unit, the extraction unit, the determination unit, and the main body controllerof the processorcan also be configured by being integrated partially or entirely into one CPU or the like.

12 FIG. Next, the operation of the ultrasound diagnostic apparatus according to the first embodiment will be described with reference to the flowchart illustrated in.

1 25 32 24 First, in Step S, by the identification unit, the determination procedure is read out from the determination procedure memory, the plurality of ultrasound images in which the same lesion part of the subject is imaged and which are stored in the image memoryare analyzed, and the characteristics of the lesion part for the determination item set in each branch of the determination procedure are identified.

1 4 FIG. For example, it is determined whether the lesion part corresponds to one of three determination items set in the first branch Bof the determination procedure illustrated in, that is, the cystic pattern, the mixed pattern, or the solid pattern.

2 26 32 1 26 25 1 Next, in Step S, by the extraction unit, the determination procedure is read out from the determination procedure memory, and at least one ultrasound image contributing to the identification of the characteristics of the lesion part in the plurality of branches of the determination procedure performed in Step Sis extracted as the basis image. in a case of determining whether or not the characteristics of the lesion part correspond to the determination item, the extraction unitextracts the ultrasound image that best represents the determination as the basis image from the plurality of ultrasound images which are analyzed by the identification unitin Step S.

For example, the likelihood of determining each characteristic corresponding to the branch of the determination procedure is scored for the plurality of ultrasound images, the characteristic with the highest score or the characteristic with the highest mean, median, or mode of the scores of the plurality of ultrasound images is selected as a branch route, and the ultrasound image with the highest score of the characteristic corresponding to the selected route is extracted as the basis image.

25 In a case where there are a plurality of ultrasound images most contributing to the identification by the identification unit, the basis image is not limited to one ultrasound image, and a plurality of ultrasound images are extracted as the basis image.

3 1 2 In a case where the basis image is extracted, the processing proceeds to Step S, and it is determined whether or not the identification of the characteristics of the lesion part in Step Sand the extraction of the basis image in Step Sare ended for all of the plurality of branches of the determination procedure.

1 25 26 2 In a case where there remains a branch for which the identification of the characteristics of the lesion part and the extraction of the basis image are not performed, the processing returns to Step S, and for the next branch in the determination procedure, the identification of the characteristics of the lesion part is performed by the identification unit, and the extraction of the basis image is performed by the extraction unitin Step S.

1 3 3 In this manner, Steps Sto Sare repeated until the identification of the characteristics of the lesion part and the extraction of the basis image are ended for all the branches in Step S.

3 4 27 32 27 25 Then, in a case where it is determined in Step Sthat the identification of the characteristics of the lesion part and the extraction of the basis image are ended for all the branches, the processing proceeds to Step S, and by the determination unit, the determination procedure is read out from the determination procedure memory, and the medical examination category of the lesion part is determined according to the determination procedure. In this case, the determination unitcan perform the route selection of the determination procedure by applying the characteristics of the lesion part identified by the identification unitto the determination item corresponding to each branch in the plurality of branches of the determination procedure, and thereby determine the medical examination category of the lesion part.

5 22 23 27 26 13 FIG. In a case where the medical examination category of the lesion part is determined in this manner, the processing proceeds to Step S, and as illustrated in, by the display controller, the determination procedure used in the determination of the medical examination category is displayed on the monitor, and further, the route in a case where the medical examination category is determined by the determination unitand the basis image extracted by the extraction unitare superimposed and displayed on the determination procedure.

25 The border of the lesion part determined by the identification unitcan be superimposed and displayed on the basis image.

13 FIG. 27 In, the route in a case where the medical examination category is determined by the determination unitis displayed by being emphasized by a thick line, so that it can be seen that the lesion part of the subject is determined to belong to the medical examination categories 4 and 5.

The route of the determination can be displayed by being emphasized by a line with a specific color without being limited to the thick line.

13 FIG. 1 26 1 1 In the example illustrated in, in the first branch B, it is determined that the lesion part corresponds to the solid pattern among three determination items of the cystic pattern, the mixed pattern, and the solid pattern, and the ultrasound image that best represents the determination is extracted by the extraction unit, and is displayed as a basis image Unear the branch Bin the determination procedure.

2 26 2 2 Similarly, in the branch B, it is determined that the lesion part corresponds to at least one of the border portion hyperechoic image or the rupture of the mammary gland border line, and the ultrasound image that best represents the determination is extracted by the extraction unit, and is displayed as a basis image Unear the branch Bin the determination procedure.

25 25 26 26 23 22 In this manner, the characteristics of the lesion part for the determination item in the plurality of branches of the determination procedure are identified by the identification uniton the basis of the plurality of ultrasound images in which the same lesion part of the subject is imaged, at least one ultrasound image contributing to the identification of the characteristics by the identification unitis extracted as the basis image from the plurality of ultrasound images by the extraction unit, and the route in the determination procedure in a case of determining the medical examination category and the basis image extracted by the extraction unitare displayed on the monitorby the display controller. Therefore, it is possible to determine the medical examination category of the lesion part and accurately understand the basis of the determination from the plurality of ultrasound images regardless of the skill level of the user.

26 25 25 1 22 1 14 FIG. The extraction unitcan form an enclosing line to surround a portion contributing to the identification by the identification unit, in the basis image extracted from the plurality of ultrasound images on the basis of the identification result of the characteristics of the lesion part received from the identification unit, and an enclosing line E can be superimposed and displayed on the basis image Uby the display controlleras illustrated in. Instead of the enclosing line E, a border line of the portion contributing to the identification may be superimposed and displayed on the basis image U.

26 25 1 1 1 23 22 15 FIG. Further, the extraction unitmay form a heat map in which a contribution rate of the portion contributing to the identification by the identification unitis represented by color shading or color difference, on the basis of the basis image U. As illustrated in, a heat map UH can be displayed side by side with the basis image Uon the monitorby the display controller.

1 1 1 1 29 16 FIG. Instead of displaying the heat map UH side by side with the basis image U, the basis image Uand the heat map UH may be alternately displayed on the basis of the user's input operation via the input device, as illustrated in.

1 1 25 In this manner, by superimposing and displaying the enclosing line E on the basis image Uor displaying the heat map UH, the user can intuitively understand the portion contributing to the identification by the identification unit.

25 26 1 1 17 FIG. a b In each branch of the determination procedure, in a case where a plurality of basis images contributing to the identification by the identification unitare extracted by the extraction unit, for example, as illustrated in, a plurality of corresponding basis images Uand Ucan be displayed side by side near the branch.

26 23 29 26 1 1 1 18 FIG. m m m. Alternatively, a plurality of basis images extracted by the extraction unitmay be sequentially displayed on the monitoron the basis of the user's input operation via the input device. In this case, for example, as illustrated in, a page number m/n indicating which of n basis images extracted by the extraction unitis a basis image Uthat is currently being displayed, that is, indicating what number of the basis image U, can be displayed in an overlaid manner on the basis image U

23 In a case where the plurality of basis images are sequentially displayed in this manner, even in a case where the monitordoes not have a large display space, the plurality of basis images can be displayed, and the page number is displayed in an overlaid manner so that the user can easily understand the plurality of basis images.

Further, the plurality of basis images may be sequentially and automatically displayed at certain time intervals without depending on the user's input operation.

4 FIG. 19 FIG. 25 23 As in the determination procedure illustrated in, the size of the lesion part is set as the determination item in a plurality of branches. Therefore, as illustrated in, the size of the lesion part measured by the identification unit, for example, the maximum diameter of the tumor and the aspect ratio of the mass can be displayed on the monitorby being superimposed on the determination procedure.

29 25 25 27 23 It is configured such that the region of the tumor and the region of the mass are displayed on the image and the displayed regions can be modified by the user via the input device, and the identification unitmay correct the measurement value by measuring again the maximum diameter of the tumor and the aspect ratio of the mass on the basis of the modified regions. For example, in a case where the contour lines of the displayed regions are modified by the user, the measurement values of the maximum diameter of the tumor and the aspect ratio of the mass are corrected by the identification uniton the basis of the modified region, and the medical examination category is determined again by the determination uniton the basis of the corrected measurement values. The corrected maximum diameter of the tumor and the corrected aspect ratio of the mass are displayed on the monitorby being superimposed on the determination procedure.

25 25 23 20 FIG. Further, the identification unitcan calculate a ratio of the region where the identified characteristics of the lesion part appear, to the total region of the lesion part for each set determination item of the determination procedure. For example, the identification unitcreates a three-dimensional image on the basis of the plurality of ultrasound images in which the same lesion part of the subject is imaged and which are analysis targets, and calculates the ratio of the region recognized as “rough” in the border portion of the lesion part to the entire region of the lesion part, for example. The calculated ratio can be displayed on the monitorby being superimposed on the determination procedure as illustrated in.

23 Instead of creating the three-dimensional image, for example, the lengths of the rough portion and the other portions may be calculated for each frame, such as 2 cm of the rough portion and 8 cm of the other portions in the first frame, and 1.5 cm of the rough portion and 7 cm of the other portions in the second frame, and the ratio of the sum of the lengths of the rough portions in all the frames and the sum of the lengths of the other portions in all the frames may be calculated and displayed on the monitor.

11 FIG. 21 FIG. 25 23 As described above, the shape of the mass is classified according to whether the shape including the border hyperechoic portion has a “narrow part” and an “angulated part”, and for example, the irregular shape as illustrated inhas both the “narrow part” and the “angulated part”, but it is desirable to check the number of “narrow parts” and “angulated parts” in order to recognize that the mass has an irregular shape. Thus, the number of each of “narrow parts” and “angulated parts” of the lesion part can be calculated from the plurality of ultrasound images by the identification unit, and can be displayed on the monitorby being superimposed on the determination procedure as illustrated in.

23 25 In this manner, by displaying the size of the lesion part, the ratio of the region where the identified characteristics of the lesion part appear to the entire region of the lesion part, and the number of “narrow parts” and “angulated parts” on the monitoron the basis of the analysis by the identification unit, the user can understand in more detail the basis for the route selection in the plurality of branches of the determination procedure.

12 FIG. 25 1 2 In the first embodiment described above, as illustrated in, the characteristics of the lesion part are identified for the plurality of ultrasound images by the identification unitin Step S, and the basis image contributing to the identification of the characteristics is extracted in Step S, but the embodiments of the present invention are not limited thereto.

22 FIG. 25 6 7 For example, as illustrated in the flowchart of, first, all the characteristic items stored in advance in the identification unitmay be determined for all the plurality of ultrasound images in Step S, and along with the determination, in subsequent Step S, at least one ultrasound image that best represents each characteristic item may be extracted as the basis image.

4 27 5 22 23 In this manner, in a case where the determination of all the characteristic items and the extraction of the basis image are performed, similar to the first embodiment, the processing proceeds to Step S, the medical examination category of the lesion part is determined according to the determination procedure by the determination unit, and in Step S, by the display controller, the determination procedure is displayed on the monitor, and the route in a case of determining the medical examination category and the basis image are superimposed and displayed on the determination procedure.

23 FIG. 1 FIG. 20 10 20 27 28 27 28 20 20 20 illustrates a configuration of an ultrasound diagnostic apparatus according to a second embodiment. The ultrasound diagnostic apparatus is configured by connecting an apparatus main bodyA to the ultrasound probe. The apparatus main bodyA uses a determination unitA to a main body controllerA instead of the determination unitand the main body controllerin the apparatus main bodyof the ultrasound diagnostic apparatus according to the first embodiment illustrated in, and the other configuration of the apparatus main bodyA is the same as the apparatus main bodyof the first embodiment.

27 31 31 22 The determination unitA includes a probability calculation unitinside, and the probability calculation unitis connected to the display controller.

28 21 22 24 25 26 27 32 29 28 12 10 28 The main body controllerA is connected to the image generation unit, the display controller, the image memory, the identification unit, the extraction unit, the determination unitA, and the determination procedure memory, and the input deviceis connected to the main body controllerA. The transmission and reception circuitof the ultrasound probeis connected to the main body controllerA.

21 22 25 26 27 28 30 The image generation unit, the display controller, the identification unit, the extraction unit, the determination unitA, and the main body controllerA constitute a processorA.

25 31 In a case of performing the route selection of the determination procedure by applying the characteristics of the lesion part identified by the identification unitto the determination item corresponding to each branch, the probability calculation unitcalculates the probability of route selection for each branch.

31 The calculation of the probability by the probability calculation unitcan be executed using a determination model trained using a machine learning technique such as deep learning, for example. The determination model is a trained model trained for the mammary gland region (segmentation) in the learning ultrasound images in which the breast is imaged, for example.

1 31 23 22 13 FIG. 24 FIG. For example, the probability that the lesion part corresponds to each of three determination items of the cystic pattern, the mixed pattern, and the solid pattern in the first branch Bof the determination procedure illustrated inis calculated by the probability calculation unit. As illustrated in, a probability X % that the lesion part corresponds to the cystic pattern, a probability Y % that the lesion part corresponds to the mixed pattern, and a probability Z % that the lesion part corresponds to the solid pattern are displayed on the monitorby being superimposed on the determination procedure by the display controller.

As a result, it is possible for the user to understand in more detail the basis for the route selection in each branch of the determination procedure.

2 31 13 FIG. For example, in a case where the lesion part corresponds to at least one of the border portion hyperechoic image or the rupture of the mammary gland border line in the branch Bof the determination procedure illustrated in, it is determined that the lesion part belongs to the medical examination categories 4 and 5. In this manner, in a case where the lesion part corresponds to a plurality of medical examination categories in one branch, it is possible to determine which of the plurality of corresponding medical examination categories by comparing the probability of the route selection calculated by the probability calculation unitwith a predetermined threshold value.

2 For example, in a case where the probability that the lesion part corresponds to at least one of the border portion hyperechoic image or the rupture of the mammary gland border line in the branch Bis equal to or less than the predetermined threshold value, it can be determined that the lesion part belongs to the medical examination category 4, and in a case where the probability is greater than the predetermined threshold value, it can be determined that the lesion part belongs to the medical examination category 5.

10 12 20 20 12 20 20 21 10 21 41 42 43 21 41 10 20 20 42 43 3 FIG. In the first and second embodiments described above, the ultrasound probehas the transmission and reception circuit, but the apparatus main bodiesandA can include the transmission and reception circuit. Further, the apparatus main bodiesandA have the image generation unit, but the ultrasound probemay have the image generation unit. Further, among the signal processing unit, the DSC, and the image processing unitconstituting the image generation unitillustrated in, only the signal processing unitmay be provided in the ultrasound probe, and the apparatus main bodiesandA may have the DSCand the image processing unit.

20 20 As the apparatus main bodiesandA in the first and second embodiments, a stationary type apparatus main body can be used, and a portable or handheld type compact apparatus main body can also be used.

32 32 In the first and second embodiments described above, the medical examination category of the lesion part in the mammary gland is determined according to the determination procedure stored in the determination procedure memory, but the embodiments of the present invention are not limited thereto, and by storing the determination procedure for determining the medical examination category regarding the thyroid gland in the determination procedure memory, similarly, the medical examination category of the lesion part in the thyroid gland can be determined according to the predetermined determination procedure having a plurality of branches.

32 Further, by storing the determination procedure for performing not only the determination of the medical examination category but also the determination of the diagnosis category in the determination procedure memory, the embodiments of the present invention can be similarly applied to the determination of the diagnosis category.

Diagnosis category I: normal Diagnosis category II: normal or inflammatory cell Diagnosis category Ma: benign cell but malignancy cannot be ruled out Diagnosis category Mb: high probability of malignancy but benignancy cannot be ruled out Diagnosis category IV: suspicious of malignancy Diagnosis category V: malignant JABTS defines diagnosis categories I to V as follows.

By using the ultrasound diagnostic apparatus according to the embodiments of the present invention, similar to the medical examination category, it is possible to determine the diagnosis category of the lesion part in the mammary gland or thyroid gland from the plurality of ultrasound images and to accurately understand the basis for the determination regardless of the skill level of the user.

10 : ultrasound probe 11 : transducer array 12 : transmission and reception circuit 13 : pulser 14 : amplification unit 15 : AD conversion unit 16 : beam former 20 : apparatus main body 21 : image generation unit 22 : display controller 23 : monitor 24 : image memory 25 : identification unit 26 : extraction unit 27 27 ,A: determination unit 28 28 ,A: main body controller 29 : input device 30 A: processor 31 : probability calculation unit 32 : determination procedure memory 41 : signal processing unit 42 : DSC 43 : image processing unit 1 2 B, B: branch M: mass N: tumor H: border hyperechoic portion 1 2 L, L: maximum length 3 L: maximum width W: horizontal diameter D: vertical diameter 1 1 1 1 2 a b m U, U, U, U, U: basis image E: enclosing line 1 UH: heat map